| CTRI Number |
CTRI/2023/05/053152 [Registered on: 26/05/2023] Trial Registered Prospectively |
| Last Modified On: |
16/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Time to heal following femur shaft fractures treated by large diameter rods and bolting nails inside medullary cavity. |
|
Scientific Title of Study
|
Time to union following femur shaft fractures treated by interlocking nail. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ishani Singh |
| Designation |
UG Student (MBBS) |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Orthopaedics, Kasturba hospital, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9818774476 |
| Fax |
|
| Email |
ishanisingh456@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shyamasunder Bhat N |
| Designation |
Professor and Head |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Orthopaedics, Kasturba hospital, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9480486075 |
| Fax |
|
| Email |
shyambhat.n@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ishani Singh |
| Designation |
UG Student (MBBS) |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Orthopaedics, Kasturba hospital, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9818774476 |
| Fax |
|
| Email |
ishanisingh456@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Hospital, Manipal |
|
|
Primary Sponsor
|
| Name |
Not Applicable |
| Address |
Not Applicable |
| Type of Sponsor |
Other [Not a funded project] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Madhava Pai K |
Kasturba Medical College, Manipal |
Department of Orthopaedics, Kasturba medical college, Madhav Nagar, Manipal
Udupi
KARNATAKA |
9901729998
madhava.pai@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 (student research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S723||Fracture of shaft of femur, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients with femur shaft fracture treated by interlocking nailing between 1 January 2018 to
1 January 2019 were included in the study. |
|
| ExclusionCriteria |
| Details |
The patients without a minimum two-year post
operative follow up were excluded. Patients with pathological femur shaft fracture were also
excluded. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time to union.
Number of patients with non union.
Modified radiological union score at final follow-up.
|
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim: To determine effectiveness of interlocking nailing in treatment of femur shaft fracture.
Justification for study: Most available literature on interlocking nailing in the treatment of femur shaft fracture is based on western literature. In the current study we attempt to determine the time taken for fracture union in femur shaft fracture following interlocking nailing in Indian population to see if there is any difference from western literature.
Description of process: Two independent observers will be retrospectively studying the time taken to heal after treatment by interlocking nails in patients with femur shaft fracture between 1 January 2018 to 1 January 2019. Data will be analyzed by two different observers in a blinded fashion. The statistical analysis will then be done using SPSS for windows version 21. |